Combination Drug/Device Products CGMPs - Final Rule

Why Should You Attend:

There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they've considered the applicable elements of the pharma and device CGMPs, 21 CFR 210/211 and 820; sometimes with ambiguous advice from the agency, resulting in some disagreements during compliance audits.

Do not let yourself or your company be caught off guard by the new CGMP requirements for combination products. Attend this training to enhance your awareness of these new cGMP requirements and modify internal audits to match this FDA shift. This training will be a step-by-step review of the key elements of the U.S. FDA's new final rule, "Current Good Manufacturing Practice Requirements for Combination Products", 21 CFR Part 4. The presenter will evaluate and clarify many of the pertinent issues and questions that arise involving combination products.

This session will provide valuable assistance to all regulated companies in evaluating their existing or proposed CGMP compliance and internal audit emphasis for the production of combination products, as a sub-contractor or primary manufacturer. Once you have recognized the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure compliance to the new rule.

Areas Covered in the Webinar:

• The Four Basic Types of Combination Products
1. two or more of device, drug, biologic;
2. physically combined; or
3. packaged together; or
4. packaged separately but intended for use only with another, different type of medical product ("cross-labeling").
• The CGMP "Operating System"
• Constituent Parts
• Applicability of 21 CFR 210/211, 600-680, 820, and 1271
• The Two Ways to Compliance
• Single-type Constituent Part Facilities
• How to Address CGMP "Conflict"

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, medical device, and biologics fields. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality assurance
• Production
• Engineering
• All personnel involved in a U.S. FDA-regulated environment; especially those involved in CGMP compliance of affected regulated combination medical products

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

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